one quality for enterprise excellence...quality excellence goes beyond quality and regulatory...
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One Quality
For Enterprise Excellence
Ken Hayward
Portfolio Management for QRC
Dassault Systèmes BIOVIA
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OverviewQuality Excellence goes beyond quality and regulatory compliance, it delivers high performance
and improvement throughout and beyond the organization.
Learn about BIOVIA's vision of the future of quality through a comprehensive multi-faceted
approach in Pharma and Biotech, and how we help Life Sciences Organisations to achieve it.
Key topics include:
What an integrated comprehensive solution for quality excellence can look like
How to achieve and leverage a single source of truth for your quality data and documentation
The benefits of a total quality approach for achieving business performance excellence
Examples of client use cases
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Lifecycle Management BenefitsThe solution delivers cross-functional collaboration along a rigorous end-to-end change control process.
It introduces a fundamentally new way of working to ensure compliance
Secure Framework for
Single Source of the Truth
Reduce cost of managing global quality
Automated Change Control
Improve traceability, reliability & speed of
supply chain and regulatory changes
From Transactional to
The Automation of regulatory dossier creation
Improve regulatory preparation &
filling efficiency
From Siloed Organizations to
Flexibility in a Global Company
Continual improvement of the
manufacturing process
From Capacity Maximization to
Cycle Time Optimization
Reduce cost & delays
Real time business impact to increase visibility & speed
Enhance Use of
Impact Analysis for Post-approval Change Management
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Through Technology:
Collaboration and Control in a Global World
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With the trend toward a globalized, virtual environment quickly becoming a reality in the
Life Sciences community today the need to exchange knowledge across oceans and
firewalls has never been greater. While there are a number technologies around to meet
this need, very few of them address the unique set of requirements we have in our
industry. The strict requirement for access control, as well as version control and an
unbreakable Audit Trail mean that old school solutions like email, FTP and Dropbox will not
work today.
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Therapeutic development
can be expensive
slow
high risk…
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Let knowledge-driven innovation elevate your view
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Challenges of the Life Science Industry
$2.6B and 12-14 Years to Market New DrugsDeclining R&D Productivity
80% of APIs Manufactured in India and ChinaGlobalization
Unsustainably High Clinical Failure Rates 10.4% Likelihood of Approval from Phase 1
Increased Competition 85% of Prescriptions Fulfilled by Generics
Patent Expiration $ 66 B Sales off Patent in 2015
Lower Margins Discounts of 27% to 49% off List Price
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Challenges of the Life Science Industry
Open Scientific
Innovation Innovating in a Collaborative Development EnvironmentKey business changesUnify access across applications and Cloud
Consistent data access across applications both in-house and in the cloud
Delivering Business ObjectivesEradicate (dark) data silos
Enables efficient collaboration and effective decision support
$2.6B and 12-14 Years to Market New DrugsDeclining R&D Productivity
80% of APIs Manufactured in India and ChinaGlobalization
Unsustainably High Clinical Failure Rates 10.4% Likelihood of Approval from Phase 1
Increased Competition 85% of Prescriptions Fulfilled by Generics
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Material management
Chemical inventory
Sample Management
Experiment management
Resource management
Process Simulation
Document management
Quality management
Data capture
Data Analysis
Result Management
Analysis
Vision
Value
Solution
Enterprise
Interoperability –
Foster Sustainability &
Compliance
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Process Portfolios for Science-Based Enterprises
IDEATION R&DRegulatory
ApprovalProduction
Product Development ECOSYSTEM
Unified Lab Management
Process Production Operations
Quality and Regulatory Management
Collaborative Science
Process Design
Process Performance
Process Improvement
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PROGRAMMANAGEMENT
PRODUCT
MARKETING
QUALITY
MANAGEMENT
REGULATORY
AFFAIRS
SALES & SERVICE SUPPORT
R&D
CLINICAL
Formulation
Supply Chain Development Supply Chain Management
Manuf. Process & Equipment Development
Pilot Production Production Launch Plan & Scale Up
Manufacturing Feedback
Maintenance / Sustaining Engineering
Prod. Phase OutProductionPack & Label Development Pack & Label Verification
Raw materials purchasing
Plant management Track & Trace
Bioinformatics
Combinatorial chemistry
Genomics
Biological Engineering
PK/PD Studies
Pharmacology & Safety
Screening
Clinical Supplies Management & Testing (Release & Stability)
Predictive Sciences
Process/BioProcess Dev/Optimization, Scale up
Analytical Method Dev/Optimization Validation
Toxicology
C-Level Execution (CEO, CFO, CMO…)
Business Development / Licensing & Alliances
Intellectual Property Protection Fiscal / LawFinance
Investigational data collection
Clinical Study registration
Transparency / Market Access
Regulatory submission
eCTD productionPost-market regulatory
activities
Regulatory Plan Regulatory dossierPromotional activities
Reg. rev
Annual Product Review Regulatory tracking / Strategy
Marketing Strategy
Marketing Studies / Epidemiology Pricing / Reimbursement Operational Marketing
Business case assessment Business case assessment
Simulations
API verification
Pharmacovigilance / Drug Safety
Quality Assurance / Quality Control
DSURs SUSARs PSURs
Corrective And Preventive Action (CAPA) & Change
Quality SupportQuality Management / Standard Operating Procedures / Training Documents Specs Management
Audit / Calibration / Qualification / Validation
Manufactured Product quality Batch Release
Biometry / Biostatistics / Data Management
Medical & Pharmaceutical Training
Medical information & communication
Medical Strategy Clinical studies
Post-marketing Surveillance
Tech Transfer
Evergreening
Decision Support
MANUFACTURING& SUPPLIERS
CRO/CMO Management
Product Support AnalysisTechnical Information Creation & Delivery
Bioinformatics
Chemistry
Predictive Sciences
Decision Support
Pharma Industry Process MapMarketing &
PharmacovigilanceLaunchRegulatoryDevelopmentDiscoveryExploration End of Life
Portfolio/Product Management
Sales effectiveness / Merchandising
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Insert Poll Question 1 Here
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Platform Consolidation Key IssuesCompanies are tired of dealing with multiple vendors for different system requirements.
Some of the reasons being:
No common vision for the customer
Logistical difficulties
Integration headaches
Upgrade path challenges
Negotiation power is reduced
Global trend now is towards companies finding a one-stop shop for all their needs who
can grow together with their vendor.
Vendors increasingly being looked at as partners of the customer.
More and more vendors are now merging to meet this goal.
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Off the Shelf Deployments An out-of-the-box (GAMP 5 Category 3) implementation has less validation overhead than
a bespoke configured system (GAMP 4 Category 4).
Companies want systems to be implemented quickly as they can’t afford lengthy
implementations. This could be due to a deadline or simply a lack of internal resources.
Companies, especially in Asia, are seeking a best practice as often this will be the first
time they have implemented a system from the previous paper based system.
Companies want to start simple and reduce decision complexity within the project.
Off-the shelf deployments cost less than bespoke deployments.
Companies want a tried and tested system design that is already being used successfully
by other companies.
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Process to Goal - Collaboration Maturity Model
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Note – Climbing the Maturity MatrixProcess Modeled, Monitored
& Managed
Process Understood & Exchanged
Process Documented
Digital Basis “Bring Data Home”
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Contextualization: Linking Data and Metadata
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Interoperability Solution Benefits
Broadened access to research and expertise of external partners
Cloud-based collaboration across strategic partners
Cost reduction of externalized routine work
Streamlined spin-up and spin-down externalized collaborations
A greater number of successful projects
Overall process-improvement enhances research productivity
Increased duration of patent exclusivity
Innovate faster and streamlined operations get to IND/BLA sooner
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Shortening Time to Market: 2015 Challenges
LNS Research, 2015
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Quality Management: 2015 Challenges
LNS Research, 2015
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Insert Poll Question 2 Here
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Integrating the Manufacturing
Process and Quality Enterprise
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Process Development
AND
Technical Operations
Process Sciences
Process Development
AND
Technical Operations
Process Sciences
Collaborative Business Value
Annotate, Index, Search, Collaborate
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Collaborative Business ValueManufacturing Sites
Lab Techs
Plant Operators
Quality Assurance
Process Development
Technical Operations
Process Sciences
Shop Floor, Operators
Plant Supervisors
Operations Executives
Collaborate
CMOs
Development
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Customer Value
87%material use
reductionMultiple
Overlapping
SystemsDisparate
Data
FormatsData
Silos
50%FDA
inspection
time
reduction
95%reduction data
aggregation
time $20M savings in
batch failure
reduction
90%time reduction
to generate
APRs 1 month
- 1 hourroot cause
investigationMission
Critical
for process
performance
excellence
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95%time savings
$20-
35Mquality cost
savings15%productivity
improvement
up to
87%cost savings
Value of One Quality
• Automated data aggregation and reporting
• Robust & sustainable processes
• Identify & correct variability
• Reduce recalls & inspection time
• Support Quality-by-Design
• Tech transfer & data-based decision making
• Knowledge retention & collaboration across geos
• Lower resource use & cost with improved yield
• Reduced operational & tech transfer costs
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Moving Beyond Compliance
Enterprise Excellence
Operational Excellence
Quality Excellence
Regulatory Compliance
Regulatory ComplianceProcedures
Quality ExcellenceControlled Processes
Operational Excellence Integrated Quality
Enterprise ExcellencePlatform Based
for Digital Continuity
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Relying on One Single Version of the Truth
Open Integration Platform
Business Manufacturing Quality Control Documentation
One Portal
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BIOVIA One Quality
Processes
MetricsProcess Data
Quality Data
Operations, Business
Development Manufacturing Quality Control
Raw MaterialsMaterials Finished Products
Documentation
Data, Records (Evidence)
Work Instructions, Methods, Specifications
Procedures
Policy
Research
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BIOVIA One Quality
Processes
MetricsProcess Data
Quality Data
Operations, Business
Development Manufacturing Quality Control
Raw MaterialsMaterials Finished Products
Documentation
Data, Records (Evidence)
Work Instructions, Methods, Specifications
Procedures
Policy
Research
Document Management
Process Management
Materials and Sample Management
Data Monitoring, Analysis, Reporting
Ideation, Research
Method / Procedure Development
Batch Execution,
EBRLab Management,
Lab Execution
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BIOVIA One Quality
End-to-End
Quality
Enterprise
Excellence
One Portal –
One Truth
BIOVIA
One Quality
Manufacturing
Discovery, Ideation
Development
Regulatory Approval
Research
Commercialization
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BIOVA One Quality – Benefits Summary Reduced Costs
through insights and pre-emptive actions
Improved Compliancethrough improved processes
Improved Product Quality with increased consistency and reliability
Improved Productivity with improved planning and execution
Improved Oversight and Decision Makingthrough better collaboration and metrics
Resulting in:
Enterprise Excellence & Brand Protection
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Questions?
For more information:
Thank you for
your time today!
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